Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gerard Medical Enterprises, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
262 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954258 | TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) | Gerard Medical Enterprises, Inc. | 1996-05-24 | 262 | 12 |
| K945250 | TRIMPORT | Gerard Medical Enterprises, Inc. | 1995-03-07 | 130 | 7 |
| K942623 | TRIMPORT | Gerard Medical Enterprises, Inc. | 1994-08-23 | 88 | 7 |
| K922147 | DUAL PLASTIC VASCULAR ACCESS SYSTEM | Gerard Medical Enterprises, Inc. | 1992-12-04 | 211 | 0 |
| K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT | Gerard Medical Enterprises, Inc. | 1992-01-02 | 178 | 0 |
| K912111 | MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE | Gerard Medical Enterprises, Inc. | 1991-10-08 | 148 | 0 |
| K903364 | GERARD MEDICAL, INC. TRIM-PORT | Gerard Medical Enterprises, Inc. | 1990-10-31 | 97 | 8 |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | Gerard Medical Enterprises, Inc. | 1981-12-29 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda